Lung CancerNCT06216782
Exploring the Frontiers of Neoadjuvant Therapy for Lung Cancer: a Prospective Observational Real-world Study
An observational study of Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
Lung cancer is a malignant tumor with the highest incidence and mortality rate of cancer patients worldwide. Traditional treatments for lung cancer include surgery, radiotherapy and chemotherapy, etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Non-intervention
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2023to 30 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received neoadjuvant therapy at Shanghai Pulmonary Hospital during the study period.
Who may be able to join
- Age greater than or equal to 18 years;
- Pathohistologically confirmed diagnosis of non-small cell lung cancer or small cell lung cancer;
- Received neoadjuvant therapy after diagnosis;
- Written informed consent.
Who cannot join
- Patients enrolled in other clinical trials;
- Patients refused enrollment in this study;
- Patients refused follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Peng Zhang, Ph.D., 021-55672180, zhangpeng1121@tongji.edu.cn
About this study
Lung cancer is a malignant tumor with the highest incidence and mortality rate of cancer patients worldwide. Traditional treatments for lung cancer include surgery, radiotherapy and chemotherapy, etc. Although the growth and spread of the tumor can be controlled to a certain extent, the cure rate for patients with progressive stage is still low and the prognosis is poor.
Neoadjuvant therapy intends to use chemotherapy, immunotherapy, and targeted therapy to reduce the size and load of the tumor before surgery, to improve the surgical resection rate and therapeutic effect.
- Primary research objective: to explore the therapeutic efficacy of patients with different characteristics under different neoadjuvant therapeutic regimens.
- Secondary objectives To investigate the strengths and weaknesses of different neoadjuvant regimens in real-world clinical practice, and to investigate the long-term outcomes of patients treated with different regimens.
Read the detailed description
Lung cancer is a malignant tumor with the highest incidence and mortality rate of cancer patients worldwide. Traditional treatments for lung cancer include surgery, radiotherapy and chemotherapy, etc. Although the growth and spread of the tumor can be controlled to a certain extent, the cure rate for patients with progressive stage is still low and the prognosis is poor.
Neoadjuvant therapy intends to use chemotherapy, immunotherapy, and targeted therapy to reduce the size and load of the tumor before surgery, to improve the surgical resection rate and therapeutic effect. In lung cancer treatment, neoadjuvant therapy has rate and quality of life. However, a meta-analysis confirmed that although neoadjuvant chemotherapy can significantly improve survival compared to surgery alone, with an OS HR of 0.8, the improvement in 5-year survival is only 5%. Neoadjuvant radiotherapy alone, even if it can lead to pathological remission in resected specimens, does not improve resectability or overall survival. The goal of preoperative radiotherapy is to improve OS by reducing local tumor recurrence, which is the primary goal in patients with Pancoast syndrome, for example, in whom localized lung loss has an impact on quality of life. In the literature, it has been reported that in the early treatment experience of patients with Pancoast syndrome, the percentage of incompletely resected tumors was reduced by neoadjuvant radiotherapy. The MPR or pCR rate of neoadjuvant NSCLC treatment with conventional chemotherapy and radiotherapy is less than 10%, and the improvement in 5-year overall survival is only 5%, suggesting that its efficacy is very limited.
- Primary objective The primary objective of the study is to explore the efficacy of neoadjuvant therapy in patients with different characteristics under different neoadjuvant therapy regimens.
- Secondary objectives To investigate the strengths and weaknesses of different neoadjuvant regimens in real-world clinical practice, and to investigate the long-term outcomes of patients treated with different regimens.
- Conditions
- Lung Cancer
- Being tested
- Non-intervention
- Keywords
- Neoadjuvant therapy; Lung cancer; Long-term survival
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionOther
Non-intervention
| Study group | Role | What they receive |
|---|---|---|
| Non-small cell lung cancer patients receiving neoadjuvant therapy | Patients diagnosed with non-small cell lung cancer who received neoadjuvant therapy. Receives: Other: Non-intervention | |
| Small cell lung cancer patients receiving neoadjuvant therapy | Patients diagnosed with small cell lung cancer who received neoadjuvant therapy. Receives: Other: Non-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
The time from diagnosis until progression, recurrence, or death from any cause.
Measured: 5 years
Secondary outcomes (1)
Surgical conversion rate and objective response rate (ORR)
Surgical conversion rate: the rate of the conversion from the unresectable lung cancer before treatment to resectable after inducation therapy.
Objective response rate (ORR): the proportion of patients with a complete response or partial response to induction therapy according to Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start16 Dec 2023
- Primary completion30 Dec 2033 (estimated)
- Study completion30 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Peng Zhang, Ph.D., Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216782
- Sponsor's protocol ID
- RW-LungMate
- Status last verified
- Jan 2024
- First submitted
- 16 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Frontiers of Neoadjuvant Therapy for Lung Cancer: a Prospective Observational Real-world Study
- ClinicalTrials.gov ID
- NCT06216782
- Acronym / sponsor ID
- RW-LungMate
- Conditions
- Lung Cancer
- Keywords
- Neoadjuvant therapy; Lung cancer; Long-term survival
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 16 Dec 2023 (actual)
- Primary completion
- 30 Dec 2033 (estimated)
- Study completion
- 30 Dec 2033 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer is a malignant tumor with the highest incidence and mortality rate of cancer patients worldwide. Traditional treatments for lung cancer include surgery, radiotherapy and chemotherapy, etc. Although the growth and spread of the tumor can be controlled to a certain extent, the cure rate for patients with progressive stage is still low and the prognosis is poor.
Neoadjuvant therapy intends to use chemotherapy, immunotherapy, and targeted therapy to reduce the size and load of the tumor before surgery, to improve the surgical resection rate and therapeutic effect.
- Primary research objective: to explore the therapeutic efficacy of patients with different characteristics under different neoadjuvant therapeutic regimens.
- Secondary objectives To investigate the strengths and weaknesses of different neoadjuvant regimens in real-world clinical practice, and to investigate the long-term outcomes of patients treated with different regimens.
Detailed description
Lung cancer is a malignant tumor with the highest incidence and mortality rate of cancer patients worldwide. Traditional treatments for lung cancer include surgery, radiotherapy and chemotherapy, etc. Although the growth and spread of the tumor can be controlled to a certain extent, the cure rate for patients with progressive stage is still low and the prognosis is poor.
Neoadjuvant therapy intends to use chemotherapy, immunotherapy, and targeted therapy to reduce the size and load of the tumor before surgery, to improve the surgical resection rate and therapeutic effect. In lung cancer treatment, neoadjuvant therapy has rate and quality of life. However, a meta-analysis confirmed that although neoadjuvant chemotherapy can significantly improve survival compared to surgery alone, with an OS HR of 0.8, the improvement in 5-year survival is only 5%. Neoadjuvant radiotherapy alone, even if it can lead to pathological remission in resected specimens, does not improve resectability or overall survival. The goal of preoperative radiotherapy is to improve OS by reducing local tumor recurrence, which is the primary goal in patients with Pancoast syndrome, for example, in whom localized lung loss has an impact on quality of life. In the literature, it has been reported that in the early treatment experience of patients with Pancoast syndrome, the percentage of incompletely resected tumors was reduced by neoadjuvant radiotherapy. The MPR or pCR rate of neoadjuvant NSCLC treatment with conventional chemotherapy and radiotherapy is less than 10%, and the improvement in 5-year overall survival is only 5%, suggesting that its efficacy is very limited.
- Primary objective The primary objective of the study is to explore the efficacy of neoadjuvant therapy in patients with different characteristics under different neoadjuvant therapy regimens.
- Secondary objectives To investigate the strengths and weaknesses of different neoadjuvant regimens in real-world clinical practice, and to investigate the long-term outcomes of patients treated with different regimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-small cell lung cancer patients receiving neoadjuvant therapy | – | Other: Non-interventionPatients diagnosed with non-small cell lung cancer who received neoadjuvant therapy. |
| Small cell lung cancer patients receiving neoadjuvant therapy | – | Other: Non-interventionPatients diagnosed with small cell lung cancer who received neoadjuvant therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received neoadjuvant therapy at Shanghai Pulmonary Hospital during the study period.
Key inclusion criteria (4 listed)
- Age greater than or equal to 18 years;
- Pathohistologically confirmed diagnosis of non-small cell lung cancer or small cell lung cancer;
- Received neoadjuvant therapy after diagnosis;
- Written informed consent.
Key exclusion criteria (3 listed)
- Patients enrolled in other clinical trials;
- Patients refused enrollment in this study;
- Patients refused follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionNon-intervention | Other | Non-small cell lung cancer patients receiving neoadjuvant therapy, Small cell lung cancer patients receiving neoadjuvant therapy |
Primary outcome
Event-free survival (EFS)
Time frame: 5 years
The time from diagnosis until progression, recurrence, or death from any cause.
1 secondary outcome
Surgical conversion rate and objective response rate (ORR)
Time frame: 3 to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peng Zhang, Ph.D. principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Zhang, Ph.D. (021-55672180, zhangpeng1121@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.